Human Subjects Protection Scientist
Alaka`ina Foundation Family of Companies · Silver Spring, MD · 2 mo ago
AnalystFull-time
Description of Responsibilities
- Provide human subjects protection regulatory and scientific support services via the review of research protocols submitted to the WRAIR, HSPB to include participating in project/protocol development/modification.
- Evaluate research protocols and protocol lifecycle actions (e.g., amendments, continuing reviews, safety reports, deviations, etc.) for compliance with relevant regulatory requirements and draft a Protocol Evaluation Form (PEF)/pre-review for each action received.
- Reviews and writes a variety of scientifically technical documents for the purposes of evaluating against applicable regulations, policies and procedures.
- Provides human subjects protection regulatory and scientific support services via the review of research protocols submitted to an Army command and its detachments.
- Evaluating research protocols and protocol lifecycle actions for compliance with relevant regulatory requirements and drafting a protocol evaluation form (PEF)/pre-review for each review conducted.
- Managing the approval process for these actions by drafting/triaging review/approval memoranda on behalf of the army command and its detachments.
- Developing new policies/procedures, as well as recommend revisions to existing policies and procedures, at the request of the TOCOR or HSPB Director.
- Representing HSPB at meetings pertaining to human subject protection issues, as needed.
- Participating in site assistance visits to OCONUS laboratories, as needed, and draft site assistance visit (SAV) reports following visits to OCONUS laboratories.
- Reviewing and documenting investigator’s credentials. The PEF/pre-review will include review and documentation of investigator credentials.
- Writing protocol minutes and provision of meeting minutes’ excerpts.
- Providing training in human subjects’ protection and quality of records to investigators and other staff, as needed.
- Updating the HSPB protocol database/electronic records management system in a timely manner.
- Assisting in providing support in preparation for IRB meetings, to include preparing/participating in pre-meetings, as well as, setting up/clearing up the room for the day of the meeting.
- Other duties as assigned by Supervisor.
Required Degree/Education/Certification
- Master of Science (MS) in allied sciences with two (2) years IRB regulatory experience;
- or Bachelor’s degree in allied sciences with five (5) years IRB regulatory experience.
Required Skills and Experience
- Ability to serve as the subject matter expert in required areas of expertise and provide industry best practice solutions to extremely complex problems being addressed.
- Have the ability to analyze extremely complex problems and recommend, monitor and execute best practice solutions to executive level management.
- Good written and oral communication skills, along with the ability to work well in teams.
Desired Skills and Experience
- Previous DoD regulatory experience.
Citizenship and Clearance
- Must be a U.S. Citizen
- Must be able to pass and maintain an IT III background check
Benefits
- Competitive salaries
- Eligible employees enjoy a 401K plan with company match
- Medical, dental, disability, and life insurance coverage
- Tuition reimbursement
- Paid time off
- 11 paid holidays
- Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- Bering-Alaka`ina Holdings (BAH) is a fast-growing government service provider
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans
- We are an Equal Opportunity/A